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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212909

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BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE)
0.5MG/5ML (0.1MG/ML)
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: BIORPHEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.5MG/5ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212909
Product Number: 001
Approval Date: Oct 21, 2019
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE)
10MG/ML (10MG/ML)
Marketing Status: Discontinued
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: BIORPHEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212909
Product Number: 002
Approval Date: Mar 11, 2021
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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